MAUDE Adverse Event Report: MALEM MALEM BEDWETTING ALARM; ALARM ENURESIS

Model Number M04S

Device Problems Leak/Splash (1354); Melted (1385); Overheating of Device (1437)

Patient Problem Caustic/Chemical Burns (2549)

Event Date 11/20/2017

Event Type  Injury  

Event Description

My (b)(6) son was using the malem alarm at night.The alarm exploded late one night when he was in bed.He was crying when we went to his room.It was only 30 minutes that we had put the alarm on him and left him on his bed.There is an electrical issue with this product that caused it to get super hot at night from normal use.This was a brand new alarm we purchased off the internet.As soon as batteries were put into this alarm, it started making a ticking sound and got a little warm.My son wore it and went to bed.I tucked him under the sheets and 30 minutes later this happened.He was crying loudly when i went to his room.The alarm was hot and the back case of the alarm had melted and plastic had fused to his t-shirt.The batteries have leaked out of the alarm.Hot battery acid has burnt my son's neck severely and he had blisters.I took him to the er for treatment.They gave him first aid treatment and the burns are now blisters.They have become red patches and his skin is peeling off as well.We were told to make this report by the er facility.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ALARM ENURESIS
• Manufacturer (Section D): MALEM
• MDR Report Key: 7063295
• MDR Text Key: 93188615
• Report Number: MW5073570
• Device Sequence Number: 1
• Product Code: KPN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 11/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: M04S
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 8 YR
• Patient Weight: 27